Project Abstract Biomedical Research Core 3: PKD Biomarkers Core (Core Director: Darren Wallace) The Biomarkers Core will support investigators in biomedical research involved in the discovery, validation and development of biomarkers for early PKD. The long term goal of the core is to establish a panel of blood and/or urine biomarkers that provide a minimally invasive approach to predict early PKD progression and to monitor the response to clinical treatment. N-acetyl-beta-D-glucosaminidase (NAG), neutrophil gelatinase-associated lipocalin (NGAL), monocyte chemotactic protein 1 (MCP-1), kidney injury molecule-1 (KIM-1) and cystatin-C, factors elevated by renal injury, are being considered as potential biomarkers for PKD and other forms of chronic kidney disease. A biomarker panel for the detection of these proteins, in addition to novel PKD specific factors, will be needed for sufficient sensitivity to reliably detect changes in early PKD, prior to overt decline in functional renal mass. The lack of sensitive and specific biomarkers for early PKD, at a time when clinical intervention would be most effective, is a major impediment in monitoring the response to potential therapies. The PKD Biomarkers Core will establish and maintain a repository of PKD biospecimens and patient data for investigators engaged in biomarker discovery and development. Samples will be collected from ADPKD patients and normal individuals in a longitudinal cohort study. Patients with early stages of PKD and relatively normal renal function, identified by sonography or prior MRI for total kidney volume (TKV) measurement and estimated GFR, will be enrolled in the study. Patients with a family history of PKD, but have not had a previous TKV measurement will receive a sonogram to determine eligibility prior to obtaining a baseline MRI. High quality biospecimens, including plasma, serum, DNA, urine, and urinary exosomes, as well as BUN and creatinine, will be collected annually and TKV will be determined every two years. Clinical information on medical history, current medications, risk factors, family history, co-morbidities, smoking history and caffeine and alcohol intake will be collected by a nurse coordinator. The Biomarkers Core will work with existing cores at the University of Kansas Medical Center, including the KU Cancer Center Biospecimen Repository Core Facility, Heartland Institute for Clinical and Translational Research (CTSU and Biostatistics Core), PKD Clinical Research Core, and the PKD Research Biomaterials and Cellular Models Core, and will work with Myriad-RBM, Inc. to develop a new multi-analyte biomarker panel for PKD.